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EC number: 261-874-9 | CAS number: 59709-38-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The test substance has no skin sensitising effects.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From May 13, 2002 to May 21, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- male mice instead of female mice were used; groupe housing instead of single housing; no body weight measurement
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK
- Sex: male
- Age at study initiation: young adults
- Weight at study initiation:
- Housing: 4/cage
- Diet (e.g. ad libitum): RM1 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 d
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: The main study was initiated on 13 May 2002. The experimental phase started on 14 May 2002 and was completed on 21 May 2002.
For the positive control study, the experimental phase started on 18 September 2001 and was completed on 25 September 2001. - Vehicle:
- other: acetone
- Concentration:
- 3%, 10% and 50% w/v
- No. of animals per dose:
- groups of 4 males
- Details on study design:
- Groups of four male mice were used for this study. Approximately 25 µL of a 3%, 10% or 30% w/v preparation of the test substance in acetone was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using acetone alone. The procedure was repeated daily for 3 consecutive days.
Three days after the third application, all animals were injected, via the tail, with approximately 250 µL of PBS containing about 20 µCi of a 2.0Ci/mmol specific activity 3H-methyl thymidine (for beta-scintillation counting using a Packard Tri-Carb 2500TR Liquid Scintillation Counter). After 5 d, the animals were sacrificed. The draining auricular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a container of PBS.
The results are expressed as a counts per minute (cpm) value per lymph node for each group. The stimulation index for each test group is then calculated by dividing the cpm value per lymph node by the equivalent value for the control (vehicle only) group.
The criterion for a positive response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. The assay is able to identify those materials that elicit responses in standard guinea pig tests for skin sensitisation (Kimber et al 1994). Consequently, a test substance which does not fulfil the above criterion is designated as unlikely to be a sensitiser. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 1, 3 and 10% w/v in acetone resulted in a greater than 3-fold increase in isotope incorporation at all three concentrations.
The validity of the protocol was confirmed. - Key result
- Parameter:
- SI
- Value:
- 0.83
- Test group / Remarks:
- 3% of test substance
- Key result
- Parameter:
- SI
- Value:
- 1.19
- Test group / Remarks:
- 10% of test substance
- Key result
- Parameter:
- SI
- Value:
- 1.06
- Test group / Remarks:
- 30% of test substance
- Cellular proliferation data / Observations:
- The application of the test substance at concentrations of 3%, 10% and 30% w/v in acetone resulted in an increase in isotope incorporation which was less than 3-fold at all three concentrations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was considered to be not sensitizing to mouse skin (LLNA).
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 (local lymph node assay), in compliance with GLP. Male CBA/Ca mice were exposed to the test substance at concentrations of 0, 3, 10 and 30% in acetone. Isotope (3H-methyl thymidine) incorporation was measured in lymph nodes. The negative (vehicle alone) and positive (hexylcinnamaldehyde at concentrations of 1, 3, and 10% w/v in acetone) controls were valid. The isotope incorporation was increased by less than a threefold at all concentrations of the test substance. Under the study conditions, the test substance was considered to be not sensitizing to mouse skin (Johnson, 2002).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Type of study:
- not specified
- Justification for non-LLNA method:
- Study available is over 12 years old.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Ten young female Hartley-Dunkin albino guinea pigs obtained from Redfern Animal Breeders, Jasons Farm, Old Hay, Brenchley, Kent were used for this study. They were conditioned to the laboratory environment for not less than 6 days and on the day before initial treatment they were weighed. At this time the body weights of the guinea pigs were within the range 300 - 430 g. Three animals were marginally over the body weight range required by the protocol.
Diet
The animals were allowed free access to amins water and food (Guinea pig Diet-Standard supplemented with Vit. C., BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex).
Environment
All animals were housed in a single air-conditioned room maintained at a temperature of 22 + 3°C, relative humidity 50 + 10% and exposed to natural lighting conditions. They were caged in groups of 2 in grid floor polypropylene boxes. - Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.1 ml of a 10% w/v solution
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- N,N-dimethylformamide
- Concentration / amount:
- 0.2 ml
10% w/v, 1% w/v and 0.1% w/v - Day(s)/duration:
- 1 day
- No. of animals per dose:
- 6 animals
- Details on study design:
- The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days
(days 1, 2 and 3). On Day 8, 0.2 ml of the challenge solutions (10% w/v, 1% w/v and 0.1% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The-applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank. The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
The erythema produced on each site was assessed 24 hours later (Day 9) and graded on a 6 point scale. - Challenge controls:
- The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.
- Executive summary:
A study was carried out to determine the skin-sensitising potential of test article in the albino guinea pig. The study was performed in accordance with Standard Operating Procedures.
Ten young female Hartley-Dunkin albino guinea pigs were used for this study. They were conditioned to the laboratory environment for not less than 6 days and on the day before initial treatment they were weighed. At this time the body weights of the guinea pigs were within the range 300 - 430 g. Three animals were marginally over the body weight range required by the protocol.
The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days (days 1, 2 and 3).
On Day 8, 0.2 ml of the challenge solutions (10% w/v, 1% w/v and 0.1% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank.
The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
The erythema produced on each site was assessed 24 hours later (Day 9).
Results
No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.
Referenceopen allclose all
Concentration of |
Number of |
Counts per (cpm) |
cpm per |
Test control |
0 (vehicle only) |
8 |
1092 |
1.37 |
N/A |
3 |
8 |
913 |
1.14 |
0.83 |
10 |
8 |
1303 |
1.63 |
1.19 |
30 |
8 |
1160 |
1.45 |
1.06 |
Skin reactions at challenge phase
Test article: Disperse Brown 19
Vehicle: dimethylformamide
Concentration: 10% w/v, 1% w/v and 0.1% w/v
Animal number and sex |
Weight (g) |
Skin reactions assessed at 24 hours after application |
||
10% w/v |
1% w/v |
0.1% w/v |
||
1 2 3 4 5 6 7 control 8 control 9 control 10 control |
410 410 430 321 308 318 340 355 344 351 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was carried out to determine the skin-sensitising potential of test article in the albino guinea pig. The study was performed in accordance with Standard Operating Procedures.
Ten young female Hartley-Dunkin albino guinea pigs were used for this study. They were conditioned to the laboratory environment for not less than 6 days and on the day before initial treatment they were weighed. At this time the body weights of the guinea pigs were within the range 300 - 430 g. Three animals were marginally over the body weight range required by the protocol.
The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days (days 1, 2 and 3).
On Day 8, 0.2 ml of the challenge solutions (10% w/v, 1% w/v and 0.1% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank.
The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end. The erythema produced on each site was assessed 24 hours later (Day 9).
No erythema was noted in any of the test or control animals. The test article was considered not to be a strong sensitiser.
A study was conducted to determine the skin sensitisation potential of the structural analogue according to OECD Guideline 429 (local lymph node assay) in compliance with GLP. Male CBA/Ca mice were exposed to the test substance at concentrations of 0, 3, 10 and 30% in acetone. Isotope (3H-methyl thymidine) incorporation was measured in lymph nodes. The negative (vehicle alone) and positive (hexylcinnamaldehyde at concentrations of 1, 3, and 10% w/v in acetone) controls were valid. The isotope incorporation was increased by less than a threefold at all concentrations of the test substance. Under the study conditions, the test substance was considered to be not sensitizing to mouse skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the above studies do not trigger a classification for skin sensitisation according to CLP (EC 1272/2008) criteria.
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